United States· US:63323-117_7667002e-a888-47f5-8eec-519bfb2ebfb2

Fluorouracil

A fluorouracil product containing fluorouracil, registered in United States by Fresenius Kabi USA, LLC. The same ATC class is registered in 14 of our 19 countries.

ATC L01BC02Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedFluorouracilATCL01BC02REGISTER NO.US:63323-117_7667002e…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Fluorouracil is registered in 14 of 19 countries.

Countries holding a registration under ATC L01BC02 (fluorouracil), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose

Fluorouracil · ATC L01BC02

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FLUOROURACIL
Manufacturer
Fresenius Kabi USA, LLC
Country
United States (US)
ATC code
L01BC02
ATC class
Fluorouracil
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    6332311758
    1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-58) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    6332311768
    1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-117-68) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Regulatory notes

UNII (FDA substance ID)
U3P01618RT
FLUOROURACIL
RxCUI 4492
Orange Book
A040278
APAP
DailyMed SPL labels
1 version tracked

Interactions

401 interactions on record for fluorouracil.

Graded by severity as the source publishes them — 36 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Fluorouracil · interactions on record

401 records

  • 36 severe
  • 119 moderate
  • 18 minor
  • 227 info

Most severe, free to view

  • DicoumarolB01AA01severe
  • WarfarinB01AA03severe
  • Folic acidB03BB01severe
  • CladribineL01BB04severe

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Fluorouracil in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All fluorouracil products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · 5-Fluorouracil Ebewe, Fluorouracil Accord
  • Belgium · Efflurak, Efudix
  • Bulgaria · 5-Флуороурацил “ебеве”, Флуороурацил Акорд
  • Cyprus · Fluorouracil Accord
  • Czechia · 5-Fluorouracil Ebewe, Fluorouracil Accord
  • Germany · 5-Fu Medac, Benda-5 Fu
  • Denmark · Fluorouracil Accord, Tolak
  • Estonia · 5-Fluorouracil Ebewe, Fluorouracil Accord
  • Spain · Fluorouracilo Accord, Tolak
  • Finland · Fluorouracil Accord, Tolerak
  • France · Efudix, Fluorouracile Accord
  • United Kingdom (Northern Ireland) · Efudix, Fluorouracil Accord Healthcare
  • Greece · Fluorouracil Anabiosis, Fluorouracil Opus
  • Croatia · Fluorouracil Accord, Fluorouracil Sandoz
  • Hungary · 5-Fluorouracil Ebewe, 5-Fluorouracil Sandoz
  • Ireland · Efudix, Fluorouracil Accord
  • Iceland · Flúoróúracíl Accord
  • Italy · Fluorouracil Teva, Fluorouracile Ahcl
  • Lithuania · Fluorouracil Accord
  • Luxembourg · Efflurak, Efudix
  • Latvia · Fluorouracil Accord
  • Malta · Efudix
  • Netherlands · Efudix, Fluorouracil Accord
  • Norway · Fluorouracil Accord, Tolak
  • Poland · 5-Fluorouracil Ebewe, Efudix
  • Portugal · Efflurak, Fluorouracilo Accord
  • Romania · 5-Fluorouracil, 5-Fluorouracil Ebewe
  • Sweden · Fluorouracil Accord, Fluorouracil Teva
  • Slovenia · 5-Fluorouracil Ebewe, Fluorouracil Accord
  • Slovakia · Efudix, Fluorouracil Accord

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/f767ad48-5667-4b5c-b152-c8810f25a93b
GET /v1/drugs/f767ad48-5667-4b5c-b152-c8810f25a93b?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "U3P01618RT",
    "rxcui": "4492",
    "inchikey": "GHASVSINZRGABV-UHFFFAOYSA-N",
    "display_name": "FLUOROURACIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 1
  },
  "spl_meta": {
    "beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff": {
      "match": "brand_token",
      "title": "FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "6",
      "published_date": "2026-04-20"
    }
  },
  "productid": "63323-117_7667002e-a888-47f5-8eec-519bfb2ebfb2",
  "productndc": "63323-117",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "040278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5GM/50ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 30, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 30, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Fluorouracil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUOROURACIL",
  "start_marketing_date": "20000712",
  "active_numerator_strength": "50"
}

See everything about fluorouracil.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.